Theranos, Inc., through its founder, Elizabeth Holmes, has made the decision
to void two entire years’ worth of results from hundreds of its
“Edison” blood-testing machines—those from 2014 and
2015. This move encompasses sending tens of thousands of corrected reports
to patients and doctors, which raises the question of just how many serious
health care decisions could have been made based on inaccurate data.
Spokesperson Brook Buchanan said comprehensive corrective measures have
been taken to remedy the issues associated with the proprietary “Edison”
machine used at hundreds of testing labs. The “Edison” blood
testing machine was the primary reason Theranos was valued at $9 billion,
as the device was touted as being able to perform a wide range of diagnostic
tests from just a few drops of blood. After tossing out two years’
worth of blood test results, Theranos has also issued tens of thousands
of corrected blood test results to doctors and patients to replace the
Edison blood test results.
Regulatory Sanctions Facing Holmes
The company may also face regulatory sanctions after deficiencies in its
California lab were discovered last month. It appears the “Edison”
devices failed to meet the company’s claims of accuracy on numerous
occasions. A review of the company records of Theranos showed the California
lab ran nearly 900,000 blood tests in one year alone, yet the Edison machines
often failed to meet the company’s own accuracy requirements. In
March, CMS proposed banning Holmes from the blood testing business for
at least two years, as well as revoking the California lab’s federal
license and even imposing fines against Holmes. CMS regulators claimed
the company neglected to fix major problems, and will announce a final
decision on the proposed sanctions any day.
Walgreens Threatens to Terminate Partnership with Theranos
Walgreens, one of Theranos’ biggest conduits to consumers, threatened
to terminate their partnership with Theranos back in January, unless the
company became compliant with federal regulations. In addition to problems
with the Edison blood testing machine, Theranos has also had some problems
with a traditional blood testing machine from Siemens AG in Arizona.
The Siemens machine was programmed—by Theranos—to the wrong
settings, also failing several tests which gauged the purity of water
used in the machine. The level of water purity could affect the accuracy
of blood tests performed on the Siemens machine. Some reports say that
Siemens has grown wary of the relationship with Theranos, and in an e-mailed
statement, Siemens noted that when maintained and used properly, their
machines perform to specifications.
Claims Regarding the Edison Device May Have Been Misleading
Two years ago, investors were lining up in Silicon Valley to back Elizabeth
Holmes and Theranos. At that time, Holmes claimed Theranos would soon
be offering as many as a thousand varieties of blood tests using only
a few drops of blood. In late 2015, however, a report in the Wall Street
Journal raised questions regarding the accuracy of Holmes’ claims.
In addition to the potential sanctions Holmes may face from CMS, she is
also currently under criminal investigation from the San Francisco U.S.
Attorney and the Securities and Exchange Commission for allegedly misleading
investors about the Edison devices’ performance. Despite the vortex
of trouble currently surrounding Holmes, Theranos is planning to open
a new lab in Harrisburg Pennsylvania, although this laboratory will use
standard blood testing machines. It remains to be seen whether these latest
problems with Theranos will ultimately be the downfall of the company,
as well as Holmes’ downfall.
Contact Our National Defective Product Attorneys
If you believe you were the victim of an abnormal blood reading and it
caused you unnecessary medical tests, medical fees, and/or complications,
it is important to review all of your legal options. The national consumer
class action lawyers at Golomb & Honik, P.C. believe in holding negligent
manufacturers responsible for the damage their products have caused. Whether
you have incurred financial losses or injury, you have a right to be compensated.
To learn more about your legal options or to schedule a free consultation,
call Golomb & Honik, P.C. today at
(215) 278-4449, or fill out an online